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EC number: 701-171-0 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- February 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP OECD 471 guideline-compliant study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of 2,4,6-tris(1-phenylethyl)phenol and 2,6-bis(1-phenylethyl) phenol
- EC Number:
- 915-333-5
- IUPAC Name:
- Reaction mass of 2,4,6-tris(1-phenylethyl)phenol and 2,6-bis(1-phenylethyl) phenol
Constituent 1
Method
- Target gene:
- Histidine gene (His)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 102
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: intact excision repair system (uvrB+)
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver microsomal fraction (S9) mix
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500 and 5000 µg/plate for all strains, test conditions (+/- S9 mix) and assay replicates
- Vehicle / solvent:
- - Vehicle used: acetone
- Justification for choice of vehicle: most suitable diluent for test substance
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without S9: hydrazine, 9-aminoacridine, doxorubicine or mitomycin C / With S9: 2-aminoanthracene, 2-aminofluorene
- Remarks:
- none
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
- In agar (plate incorporation): with or without S9 mix
- Preincubation: replicate assay with S9 mix
DURATION
- Preincubation period: 20 minutes at 37°C
- Exposure duration: 72 hours
- Expression time (cells in growth medium): 72 hours
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):
SELECTION AGENT (mutation assays): histidine
SPINDLE INHIBITOR (cytogenetic assays): not applicable
STAIN (for cytogenetic assays): not applicable
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: not applicable
DETERMINATION OF CYTOTOXICITY: no cytotoxicity observed
OTHER EXAMINATIONS:
- Determination of polyploidy: not applicable
- Determination of endoreplication: not applicable
- Other: no data
OTHER: no data - Evaluation criteria:
- Response considered positive if:
- the number of revertant colonies is significantly higher than the number of revertants in solvent controls, and
- either a dose-response is verified (positive correlation between number of revertants and dose in an interval of at least 3 concentrations), or a statistically significant increase is recorded at one dose only, when confirmed in independent experiments - Statistics:
- - Student's "t" test: number of revertant colonies
- Linear regression test: dose-response relationship
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- No data
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
The detailed results of the number of revertant colonies are provided below.
- First assay (plate incorporation with or without S9 mix):
| Number or revertants per plate (Mean +/- Standard Deviation, for 3 plates) | ||||||||||
| TA1535 | TA1537 | TA98 | TA100 | TA102 | ||||||
| Concentration (µg/plate) | - S9 | + S9 | - S9 | + S9 | - S9 | + S9 | - S9 | + S9 | - S9 | + S9 |
| 0 (solvent) | 19.33 +/- 4.93 | 19.00 +/- 2.00 | 9.00 +/- 2.65 | 6.67 +/- 1.53 | 38.33 +/- 8.62 | 39.33 +/- 3.06 | 160.00 +/- 13.12 | 165.33 +/- 16.04 | 258.00 +/- 21.66 | 245.67 +/- 62.07 |
| 50 | 18.00 +/- 1.00 | 20.33 +/- 5.51 | 8.33 +/- 1.16 | 9.00 +/- 1.00 | 34.00 +/- 5.57 | 43.33 +/- 4.04 | 141.00 +/- 25.87 | 166.33 +/- 10.60 | 255.67 +/- 9.29 | 284.00 +/-9.54 |
| 150 | 16.33 +/- 3.06 | 19.00 +/- 2.65 | 9.33 +/- 2.08 | 9.33 +/- 2.08 | 35.67 +/- 3.79 | 39.00 +/- 8.72 | 144.67 +/- 18.58 | 157.00 +/- 23.07 | 247.67 +/- 20.82 | 261.33 +/- 27.06 |
| 500 | 21.00 +/- 1.73 | 19.33 +/- 3.51 | 7.33 +/- 3.06 | 8.33 +/- 2.52 | 35.33 +/- 1.53 | 37.00 +/- 5.20 | 143.33 +/- 7.57 | 160.33 +/- 19.14 | 253.00 +/- 12.77 | 268.67 +/- 10.26 |
| 1500 | 16.33 +/- 1.53 | 16.33 +/- 2.08 | 6.00 +/- 0.00 | 8.67 +/- 1.53 | 33.33 +/- 2.52 | 39.00 +/- 5.29 | 147.33 +/- 16.17 | 156.33 +/- 18.50 | 250.67 +/- 17.01 | 270.33 +/- 14.57 |
| 5000 | 19.33 +/- 4.04 | 18.00 +/- 2.00 | 5.67 +/- 3.06 | 9.33 +/- 2.08 | 32.00 +/- 8.66 | 37.33 +/- 7.02 | 154.67 +/- 17.04 | 160.67 +/- 23.18 | 247.33 +/- 18.50 | 287.67 +/-6.81 |
| Mutagenicity | Negative | Negative | Negative | Negative | Negative | Negative | Negative | Negative | Negative | Negative |
| Positive control | 96.00 +/- 16.00 | 132.00 +/- 16.70 | 49.33 +/- 7.51 | 111.33 +/- 16.07 | 696.67 +/- 68.54 | 818.00 +/- 74.05 | 538.67 +/- 131.47 | 859.33 +/- 64.66 | 1276.00 +/- 129.26 | 738.67 +/- 60.04 |
- Second assay (plate incorporation without S9 mix and pre-incubation with S9 mix):
Number or revertants per plate (Mean +/- Standard Deviation, for 3 plates) |
||||||||||
| TA1535 | TA1537 | TA98 | TA100 | TA102 | ||||||
| Concentration (µg/plate) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
| 0 (solvent) | 26.00 +/- 2.00 | 18.33 +/- 3.22 | 11.00 +/- 2.65 | 9.00 +/- 2.00 | 38.33 +/- 4.04 | 34.00 +/- 3.61 | 153.00 +/- 15.88 | 175.67 +/- 19.86 | 256.00 +/- 16.52 | 259.33 +/- 35.23 |
| 50 | 25.67 +/- 1.16 | 21.33 +/- 3.22 | 9.67 +/- 1.53 | 10.00 +/- 2.65 | 38.00 +/- 5.00 | 34.67 +/- 5.03 | 151.67 +/- 13.50 | 158.67 +/- 26.41 | 263.33 +/- 13.61 | 276.00 +/- 18.00 |
| 150 | 24.67 +/- 1.53 | 2.00 +/- 3.61 | 10.00 +/- 3.61 | 6.67 +/- 0.58 | 38.67 +/- 4.93 | 35.00 +/- 4.58 | 153.33 +/- 12.90 | 159.67 +/- 17.90 | 256.67 +/- 20.82 | 282.67 +/- 25.48 |
| 500 | 24.33 +/- 3.22 | 18.00 +/- 1.00 | 11.00 +/- 2.65 | 8.33 +/- 1.16 | 37.00 +/- 5.00 | 37.00 +/- 3.61 | 153.67 +/- 6.03 | 165.33 +/- 11.02 | 249.00 +/- 21.00 | 253.00 +/- 6.08 |
| 1500 | 22.33 +/- 4.16 | 20.67 +/- 3.22 | 10.00 +/- 1.00 | 7.00 +/- 1.00 | 38.00 +/- 5.57 | 34.33 +/- 3.06 | 158.33 +/- 20.21 | 162.67 +/- 23.16 | 247.00 +/- 11.36 | 268.67 +/- 38.59 |
| 5000 | 22.33 +/- 1.16 | 21.00 +/- 3.61 | 9.67 +/- 2.52 | 9.00 +/- 2.00 | 36.33 +/- 1.16 | 32.00 +/- 2.65 | 149.00 +/- 20.08 | 174.67 +/- 14.05 | 242.33 +/- 12.50 | 257.33 +/- 35.23 |
| Mutagenicity | Negative | Negative | Negative | Negative | Negative | Negative | Negative | Negative | Negative | Negative |
| Positive control | 94.00 +/- 10.54 | 157 +/- 13.89 | 45.67 +/- 6.03 | 133.33 +/- 13.61 | 760.67 +/- 53.00 | 940.67 +/- 77.47 | 478.00 +/- 73.51 | 777.33 +/- 36.02 | 1398.00 +/- 91.06 | 862.67 +/- 59.34 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
TSP/DSP showed no mutagenic activity in the regulatory S. typhimurium strains of an Ames test up to the limit concentration of 5000 µg/plate in the presence or absence of mammalian metabolic activation. - Executive summary:
In a reverse gene mutation assay in bacteria (RBM study No. 970075), strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 of S. typhimurium were exposed to Tristyrenated phenol/Distyrenated phenol (75/25 molar %) in acetone at concentrations of 0, 50, 150, 500, 1500 or 5000 µg/plate in the presence or absence of mammalian metabolic activation (S9 mix). A first assay was conducted using plate incorporation with or without S9 mix. A second assay was conducted using plate incorporation without S9 mix and pre-incubation with S9 mix.
TSP/DSP was tested up to the limit concentration of 5000 µg/plate. The positive controls induced the appropriate responses in the corresponding strains. There was no evidence of induced mutant colonies over background.
Therefore, the test item was considered non mutagenic in a bacterial reverse gene mutation assay.
This study is classified as acceptable. It satisfies the requirements for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
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